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# Guidance on Diagnostic Radiology Display 510(k) Submissions
- URL: https://www.fdaweb.com/guidance-on-diagnostic-radiology-display-510-k-submissions/
- Published: 2017-10-02T12:00:00.000Z
- Updated: 2026-09-14T22:53:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139754

FDA has released a [guidance](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM484914.pdf?ref=fdaweb.com) on “Display Devices for Diagnostic Radiology” that is intended to assist industry in preparing premarket notification submissions. The document applies to current technologies, but it says FDA may request new or alternative test methods to fully evaluate the safety and effectiveness of future display technologies. FDA says the guidance does not apply to real-time displays, ultrasonic-pulsed Doppler imaging displays, medical image hardcopy displays, or imaging software and software applications.